CompletedNot Applicable

Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder

United States105 participantsStarted 2021-08-01

Plain-language summary

This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a \~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. An informed consent document voluntarily signed and dated by the subject.
✓. Subject must understand and be able to read and write in English.
✓. Enrollment in residential treatment at study site.
✓. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
✓. Subject must be willing to be randomized to treatment condition.
✓. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

✕. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
✕. Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.

What they're measuring

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Opioid Craving

Timeframe: Assessed immediately prior to discharge from residential addiction treatment facility.

Trial details

NCT IDNCT05042388

SponsorWest Chester University of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-20

Results submitted2026-01-06

View on ClinicalTrials.gov More Opioid-use Disorder trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. An informed consent document voluntarily signed and dated by the subject.
✓. Subject must understand and be able to read and write in English.
✓. Enrollment in residential treatment at study site.
✓. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
✓. Subject must be willing to be randomized to treatment condition.
✓. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

✕. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
✕. Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.

What they're measuring

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Opioid Craving

Timeframe: Assessed immediately prior to discharge from residential addiction treatment facility.